The present invention relates to an external incontinence device for medical use. Urinary incontinence, a common medical problem, is currently treated with condom catheters, invasive catheters, incontinence pads and diapers.
There are several problems associated with the current treatments, most prominent of which is a high incidence of infections. The incidence of urinary tract infections with indwelling invasive urinary catheters is well described in current medical literature. The presence of an invasive catheter in the urethra is thought to facilitate the infiltration of microorganisms. Microorganisms at the catheter entrance site ascend the catheter through the urethra into the urinary tract, thus resulting in infections. The conventional condom catheter is essentially a bag connected to a tube. This sheath is usually attached to the penis by a circumferential adhesive band. Often the attachment is inadequate and the condom catheter falls off or leaks. In other cases, the circumferential adhesive band results in irritation or even strangulation of the penis. The condom catheter design presents no barrier to the infiltration of microorganisms into the urethra. Inside the bag, the moist environment is ideal for microorganism growth. Microorganisms growing in the moist environment in the bag can enter the urethra and proceed into the urinary tract causing urinary tract infections.
Incontinence pads or diapers, whether used on male or female patients, also contribute to the onset and severity of infections because the excreted urine and/or feces contained in these devices are excellent media for bacterial growth. Such bacteria can enter the urethra because in long term care facilities personnel are often unable to change patients' diapers as frequently as recommended by good medical practice.
The second problem associated with current incontinence treatments is particularly related to the condom catheter. The conventional condom catheter causes skin maceration and irritation. The epidermis is composed of dead cells which protect the underlying living dermis cells from physical and chemical irritation and from microbial invasion. Maceration refers to the problems associated with prolonged exposure of the epidermis to moisture. When epidermal cells are exposed to moisture for a sufficient period of time, they absorb water, swell, and slough off, thus exposing the physiologically active dermal layer to whatever chemical or microbial entities are present in the immediate environment.
Maceration occurs not only when the skin is exposed to water from external sources but also when moisture is trapped against the skin surface by a water-impermeable membrane. Skin continually emits water, particularly in the genital area. If the emitted water is trapped against the skin surface by a water-impermeable membrane and is not able to evaporate, then maceration occurs.
If maceration proceeds unabated, an inflammation of cellular and connective tissue caused by the failure of the epidermis, often occurs. This inflammation is often accompanied or followed by microbial invasion, causing a cellulitis or tissue infection. Microbial invasion causes further tissue inflammation and destruction. In severe cases of cellulitis, extensive tissue destruction, necrosis or gangrene ensues, necessitating removal of the gangrenous tissues or the entire affected limb. Clearly, maintaining skin dryness is necessary to prevent the onset of maceration and further degenerative states.
The conventional condom catheter functions as a bag of moisture surrounding the penis. The condom catheter does not allow the necessary evaporation of moisture from the skin surface. Not only do the walls of the condom trap the emitted moisture against the skin surface, but urination also adds to the moisture trapped inside the condom and contributes chemical irritants, such as urea, to the enclosed area. Thus, conventional condom catheters cause maceration and skin irritation.
The maceration and skin irritation caused by condom catheters make them physically uncomfortable, and patients routinely remove them, either deliberately or inadvertently while sleeping. In addition, macerated tissue is moist and loose. Adhesive, therefore, does not adhere well to macerated skin. Thus, adding a simple adhesive to the condom catheter does not help, because the condom catheter becomes loose or falls off of the patient due to maceration under the adhesive.